Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT02629809|
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Immunoglobulin Heavy Chain Locus Variable Region Mutation Small Lymphocytic Lymphoma||Drug: Cyclophosphamide Drug: Fludarabine Phosphate Drug: Ibrutinib Other: Laboratory Biomarker Analysis Biological: Obinutuzumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||First-Line Therapy With Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (iFCG) for Patients With Chronic Lymphocytic Leukemia (CLL) With Mutated IGHV Gene and Non-Del(17p)|
|Actual Study Start Date :||March 18, 2016|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Treatment (iFCG)
See Detailed Description.
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
- Efficacy of the combination of ibrutinib, fludarabine phosphate, cyclophosphamide, and obinutuzumab defined as achievement of complete remission/complete remission with incomplete marrow recovery and bone marrow minimal residual disease-negative status [ Time Frame: 84 days ]Simon's optimal two-stage design will be employed. The proportion of patients achieving complete remission/complete remission with incomplete marrow recovery and bone marrow minimal residual disease-negative will be estimated along with the 95% confidence interval.
- Bone marrow minimal residual disease-negative status [ Time Frame: 84 days ]Will estimate the proportion of patients achieving bone marrow minimal residual disease negative, along with the 95% confidence interval. For the patients who did not achieve primary endpoint after 3 courses of ibrutinib, fludarabine phosphate, cyclophosphamide, obinutuzumab, will estimate the rate of conversion to bone marrow minimal residual disease-negative with an additional 9 courses of ibrutinib and obinutuzumab treatment, along with the 95% confidence interval.
- Incidence of treatment emergent toxicities using a Bayesian design by Thall, Simon and Estey assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: From the prior chemotherapy course to up to 84 days ]Toxicities are defined as (prolonged grade >= 3 neutropenia or thrombocytopenia) at least possibly related to the study drugs lasting > 42 days from the prior chemotherapy course; febrile neutropenia; hospitalization due to infection; early death (within first 30 days of starting treatment). Safety data will be summarized using frequency and percentage, by organ type, grade and attribution.
- Progression-free survival [ Time Frame: Up to 6 years ]The Kaplan-Meier method will be used to estimate the probabilities of progression-free survival.
- Overall survival [ Time Frame: Up to 6 years ]Log-rank tests will be used to compare subgroups of patients in terms of overall survival.
- Long-term incidence rate of secondary myelodysplastic syndrome/acute myeloid leukemia [ Time Frame: Up to 6 years ]Long-term incidence rate of secondary myelodysplastic syndrome/acute myeloid leukemia will be estimated along with 95% confidence interval.
- Long-term incidence rate of Richter's transformation [ Time Frame: Up to 6 years ]Long-term incidence rate of Richter's transformation will be estimated along with 95% confidence interval.
- Rate of complete remission (CR)/CR with incomplete marrow recovery (CRi) in subgroups of patients defined by fluorescence in situ hybridization (FISH) subtypes [ Time Frame: Up to 6 years ]Will also assess if the combination therapy results in improvement in the rate of CR/CRi in subgroups of patients defined by FISH subtypes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629809
|Contact: Nitin Jainemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Nitin Jain 713-745-6080|
|Principal Investigator: Nitin Jain|
|Principal Investigator:||Nitin Jain||M.D. Anderson Cancer Center|